UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022343
Receipt number R000025755
Scientific Title Optimization of intravenous vancomycin treatment schedule for pediatric population with Monte Carlo Simulation
Date of disclosure of the study information 2016/05/19
Last modified on 2018/12/27 01:13:53

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Basic information

Public title

Optimization of intravenous vancomycin treatment schedule for pediatric population with Monte Carlo Simulation

Acronym

Optimization of intravenous vancomycin treatment schedule for pediatric population with Monte Carlo Simulation

Scientific Title

Optimization of intravenous vancomycin treatment schedule for pediatric population with Monte Carlo Simulation

Scientific Title:Acronym

Optimization of intravenous vancomycin treatment schedule for pediatric population with Monte Carlo Simulation

Region

Japan


Condition

Condition

Patients under 18 years old who were administered intravenous vancomycin in Department of Pediatrics or Department of Pediatric Cardiology in our institute between April 1st 2011 and March 31st 2016.

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the optimal treatment schedule of vancomycin for pediatric patients with Monte Carlo Simulation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The proportion of the patients who achieved more than 400 of AUC/MIC in the present treatment strategy in our institute.

Key secondary outcomes

To compare the duration required for body temperature to be normalized between the populations with AUC/MIC above 400 and below 400.
With Monte Carlo simulation, we will optimize the treatment strategy of vancomycin so that more than 90% of the patients achieve AUC/MIC more than 400.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit

18 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who were administered intravenous vancomycin in Department of Pediatrics or Department of Pediatric Cardiology between April 1st 2011 and March 31st 2016.

Age under 18 years when vancomycin was initiated.

Written informed consent is obtained.

Key exclusion criteria

Patients with renal dysfunction.

Data unavailability exists.

Lack of informed consent.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Reo Tanoshima

Organization

Yokohama City University

Division name

Department of Pediatrics

Zip code


Address

Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

(+81)45-787-2800

Email

tanotch@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Reo Tanoshima

Organization

Yokohama City University

Division name

Department of Pediatrics

Zip code


Address

Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

(+81)45-787-2800

Homepage URL


Email

tanotch@yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Pediatrics,
Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Department of Pediatrics,
Yokohama City University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 19 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2016 Year 05 Month 12 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Pediatric patients who were administered vancomycin between April 1st 2011 to March 31st 2016 in Department of Pediatrics or Department of Pediatric Cardiology.


Management information

Registered date

2016 Year 05 Month 18 Day

Last modified on

2018 Year 12 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025755


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name